NCT05693467

Preemptive Co-infiltration of Dexamethasone Palmitate With Ropivacaine for Postoperative Pain in Major Spinal Surgery

Preemptive Co-infiltration of Dexamethasone Palmitate Emulsion With Ropivacaine for Postoperative Pain in Patients Undergoing Major Spinal Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Patients undergoing major spinal surgery usually experience moderate-to-severe postoperative pain. Inadequate pain control may lead to severe complications. Dexamethasone as an adjunctive infiltration to local anesthesia (LA) presented a superior analgesic benefit compared with LA alone in various types of surgeries. However, a recent meta-analysis showed that the additional analgesic effect of dexamethasone in incision/wound infiltration was only statistically significant, but not clinically significant, and the overall benefits were marginal. Compared with dexamethasone, dexamethasone palmitate emulsion (DXP) is a targeted lipo-steroid with stronger anti-inflammatory effect, longer-acting duration and fewer adverse effects. To date, no studies have evaluated the additive analgesia effects of DXP on incision infiltration in major spinal surgery. The purpose of this trial is to determine whether preemptive co-infiltration of DXP emulsion and ropivacaine in surgical incision will further reduce postoperative opioid requirements and pain score after spinal surgery than that of ropivacaine alone.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Dexamethasone palmitate emulsion(DXP) plus ropivacaine	The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of ropivacaine and dexamethasone palmitate emulsion(DXP). For local infiltration, a total of 30mL solution will be prepared for each group, which will include 2mL of DXP(4mg per 1mL) added to 20.5 mL of saline and 7.5mL of 1% ropivacaine added to 15mL of saline for Group A . The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.
DRUG	Ropivacaine alone	The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone. For local infiltration, a total of 30mL solution will be prepared for each group, which will include 7.5mL of ropivacaine added to 22.5mL of saline for Group B . The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-06-30
• Completion: 2023-09-30
• First posted: 2023-01-23
• Last updated: 2024-04-16

Locations

1 site across 1 country: China